Benzinga | Jul 7, 2021 07:33AM EDT

Abeona Therapeutics Announces Updated EB-101 Phase 1/2a Clinical Results In Recessive Dystrophic Epidermolysis Bullosa At The Society For Pediatric Dermatology 46th Annual Meeting

Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced updated Phase 1/2a clinical trial results up to six years following treatment with Abeona's investigational EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The data showed that investigator assessment of wound healing of 50% or greater from baseline was present in 69% of treated wounds (n=18/26) at 3 years, 93% (n=14/15) at 4 years, 80% (n=12/15) at 5 years, and 80% (n=4/5) at 6 years. The results were reported in a poster, titled "Long-Term Healing, Pain Reduction, and Patient-Reported Outcomes in Recessive Dystrophic Epidermolysis Bullosa Following EB-101 Treatment of Large, Chronic Wounds," at the Society for Pediatric Dermatology (SPD) 46th Annual Meeting.



The updated results also included investigator assessment of the presence of pain in treated wounds up to six years following treatment with EB-101. The data showed that pain was absent in all treated wounds that were evaluated at 3 years (n=26), 4 years (n=15), 5 years (n=15) and 6 years (n=5) of follow up, compared with presence of pain at baseline in 53% (n=20/38) of treated wounds. A separate survey of patient-reported pain at 3 years to 6 years following treatment with EB-101 was conducted and asked participants to rate change in pain compared with their pre-treatment state using a seven-point scale, ranging from 1 (very much improved) to 7 (very much worse). The survey data showed that 76% of the treated wounds with healing of 50% or greater were associated with improved pain scores, with 53% associated with "much/very much improved" pain scores.

"RDEB is a debilitating and life-threatening rare genetic disorder with high rates of morbidity and mortality, without an approved treatment option," said Vishwas Seshadri, Ph.D., M.B.A., Head of Research & Clinical Development of Abeona. "It is important that potential new treatments can durably address large, chronic wounds, which are the most severe wounds that cause substantial pain in patients with RDEB. The updated Phase 1/2a results showed safety and durable efficacy follow up, with EB-101 treated wounds continuing to show a considerable reduction in both wound burden and associated long-term pain for up to six years. We are excited about the data and look forward to further investigating EB-101's potential to provide durable benefit in our ongoing pivotal Phase 3 VIITAL(tm) study."